Catalog Number

-

Brand Name

The MetaNeb®System

Version/Model Number

C10000N

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

NHJ

Product Code Name

DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT

Public Device Record Key

656589cf-26fe-4424-8066-b929e239a0c9

Public Version Date

January 18, 2021

Public Version Number

4

DI Record Publish Date

September 17, 2016

Package DI Number

20887761997152

Quantity per Package

10

Contains DI Package

10887761997155

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-